V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Recall
- Recall Number
- Z-0507-2025
- Event Number
- 95580
- Firm
- KCI USA, INC.
- FEI Number
- 3009897021
- Product Code
- OMP
- Status
- Open, Classified
- Root Cause
- Use error
- Initiated
- November 5, 2024
- Posted
- November 22, 2024
- Address
- 12930 W Interstate 10, San Antonio, TX, 78249-2248
Description
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
On 11/05/2024, the firm sent an "URGENT - MEDICAL DEVICE CORRECTION" Letter to customers informing them that due to a potentially broken occlusion sensor that the Veraflo instillation therapy units may encounter a System Error 007 alarm during boot up which may delay therapy. Customer are instructed to: 1. Locate all serial numbers and Therapy Unit Software version of V.A.C. Ulta Therapy Units. 2. Perform the steps outlined in the attached test procedure for the occlusion detection sensor 3. Record the test results on the provided Field Notice Receipt and Customer Response Form. Complete all remaining fields, sign and return this form via email to [email protected]. Additional copies of the response form may be required based on the number of units in your facility. 4. For any therapy units with a FAIL test result, contact your Solventum representative to coordinate the repair/replacement of the occlusion detection sensor with your facility. If any additional issues are identified during the repair, you will be notified, and it will be the responsibility of the unit owner to determine whether to proceed with the additional services and associated costs. 5. Post this Medical Device Correction letter on or near the affected products to ensure continuous reminders of the field corrective action. For questions or assistance, contact Solventum representative, visit Solventum.com or call 800-275-4524.
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